Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

Exclusion Criteria

• •1. The participant was discontinued early from studies ARGX-113-2001 or ARGX-113-1705, unless the reason for discontinuation from study ARGX-113-1705 was to roll over into study ARGX-113-2002.
• •2. Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of investigational medicinal product (IMP)
• •3. Has any of the following medical conditions:
• •1. Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at roll-over
• •2. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk
• •3. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of investigational medicinal product (IMP).
• •Participants with the following cancers can be included at any time:
• •* adequately treated basal cell or squamous cell skin cancer
• •* carcinoma in situ of the cervix
• •* carcinoma in situ of the breast
• •* incidental histological findings of prostate cancer (TNM classification of malignant tumors stage T1a or T1b)
• •4. Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk
• •4. Received a live-attenuated vaccine within 28 days prior to study entry or plan to receive a live-attenuated vaccine during the study
• •5. A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients